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Dec 27, 2010

Cepheid Launches CE-Marked Xpert Flu IVD Test in Europe

  • Cepheid launched its CE-marked Xpert® Flu in vitro diagnostic in Europe. The test, designed to run on the Cepheid GeneXpert® system, can simultaneously detect and differentiate between influenza A, influenza B, and 2009 H1N1 influenza virus in an hour, the firm claims. European launch comes ahead of U.S. release, which is projected for early 2011.

    “The European resurgence of 2009 H1N1 highlights the critical need for accurate, rapid, and easy-to-use diagnostic solutions for all of the major influenza strains in circulation,” comments John Bishop, Cepheid CEO. “Although molecular testing is now recognized as the new gold standard for detection of influenza, testing is generally limited to highly complex laboratories, and results may not typically be available round the clock. Xpert Flu provides an easy-to-use, on-demand molecular influenza test that can assist clinicians in making real-time medical deicisions 24 hours a day.”

    Cepheid is dedicated to developing fully integrated systems and tests for genetic analysis in the clinical, industrial, and biothreat markets. Its GeneXpert System is a closed, self-contained and fully integrated automated platform that combines on-board sample preparation with real-time PCR and detection for nucleic acid analysis. The modular design of the GeneXpert System means a range configurations can be tailored to meet the broad range of testing demands of any clinical environment, Cepheid claims.

    The GeneExpert product family also includes the GeneExpert Infinity System, which features fully automated, robotic cartridge handling. Cepheid claims the platform can process up to 2,074 test results in 24 hours period, providing first results in less than 52 minutes, and requiring less than two minutes sample-preparation time per test.

    The firm already markets IVD tests for a range of acquired infections and critical infectious diseases along with assays for women’s health. Its current portfolio of Xpert tests includes the Xpert SA Nasal Complete, Xpert vanA, Xpert C. difficile, Xpert MRSA/SA SSTI, Xpert MRSA/SA BC, Xpert MRSA, Xpert GBS, Xpert EV, and Xpert HemosIL® FII & FV.


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